Office of Public Sector Information
SCHEDULE 3 continued PART 2
16. An application for a wholesale dealer’s authorisation must be made to the Secretary of State.
17. The Secretary of State must process an application for a wholesale dealer’s authorisation within 90 days of receiving it.
18.—(1) The Secretary of State must grant a wholesale dealer’s authorisation if he is satisfied that this paragraph is complied with.
(2) The authorised site must be—
(a) weatherproof;
(b) secure and lockable;
(c) clean; and
(d) free from contaminants.
(3) If the veterinary medicinal products covered by the authorisation are subject to specific storage conditions, the site must be capable of fulfilling those requirements.
(4) The authorisation holder must—
(a) have at his disposal the services of technically competent staff; and
(b) have an effective emergency recall plan.
19.—(1) The wholesale dealer’s authorisation must specify—
(a) the types of veterinary medicinal products and pharmaceutical forms that may be dealt in;
(b) the place where they are to be stored;
(c) the name and address of the person holding the authorisation;
(d) the address of the premises to which it relates;
(e) the name of the qualified person nominated to act under the Guidelines on Good Distribution Practice under paragraph 22.
(2) It may cover more than one site.
(3) It lapses if the holder does not deal in veterinary medicinal products for five years.
20. The Secretary of State may suspend or revoke a wholesale dealer’s authorisation if the holder—
(a) has not complied with these Regulations; or
(b) no longer has suitable premises or equipment.
21.—(1) A person may appeal against a refusal, suspension or revocation of a wholesale dealer’s authorisation to a person appointed for the purpose by the Secretary of State.
(2) The appointed person must consider the appeal and report in writing to the Secretary of State.
(3) The Secretary of State must give written notification of his final determination and the reasons for it.
22.—(1) The holder of a wholesale dealer’s authorisation must store veterinary medicinal products in accordance with the terms of the marketing authorisation for each product.
(2) He must comply with the Guidelines on Good Distribution Practice of Medicinal Products for Human Use(27) as if the veterinary medicinal products were authorised human medicinal products.
(3) He must carry out a detailed stock audit at least once a year.
(4) He must supply information and samples to the Secretary of State on demand.
(5) He must notify the Secretary of State if there are any changes to the information held by him.
(6) It is an offence to fail to comply with this paragraph.
23.—(1) If the veterinary medicinal product is a sheep dip of any type the provisions of this paragraph apply, and it is an offence to supply the product by retail other than in accordance with this paragraph.
(2) The supply must be to a person (or a person acting on his behalf) who holds a Certificate of Competence in the Safe Use of Sheep Dips showing that Parts 1 and 2 or units 1 and 2 of the assessment referred to in the Certificate have been satisfactorily completed and issued by—
(a) in England, Wales, and Northern Ireland by the National Proficiency Tests Council, or by NPTC Part of the City & Guilds Group; or
(b) in Scotland, by one of those organisations or the Scottish Skills Testing Service.
(3) The supplier must make a record of the Certificate number as soon as is reasonably practicable, and keep it for at least three years.
(4) If the active ingredient of the veterinary medicinal product is an organophosphorus compound, the supplier must give to the buyer—
(a) a double sided laminated notice meeting the specifications in the following sub-paragraph (unless the notice has been provided to the buyer within the previous twelve months and the supplier knows or has reasonable cause to believe that the buyer still has it available for use); and
(b) two pairs of gloves either as described in the notice or providing demonstrably superior protection to the proposed user against exposure to the dip than would be provided by gloves as so described.
(5) The notice must be at least A4 size with a laminated transparent cover, coloured and printed to scale on front and back substantially in accordance with the following two diagrams, except that in Wales it may be in Welsh as well as in English—
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24.—(1) It is an offence to use sheep dip unless this is done by, or under the supervision and in the presence of, a person who holds a Certificate of Competence in the Safe Use of Sheep Dips showing that Parts 1 and 2 or units 1 and 2 of the assessment referred to in the Certificate have been satisfactorily completed and issued by—
(a) in England, Wales and Northern Ireland by the National Proficiency Tests Council, or by NPTC Part of the City & Guilds Group; or
(b) in Scotland, by one of those organisations or the Scottish Skills Testing Service.
(2) In the case of a person who has had practical experience of sheep dipping before 1st October 2006, this paragraph does not apply until 31st December 2008.
OJ No. C 63, 1.3.94, p. 4. Back [27]
The Veterinary Medicines Regulations 2007